RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the tight timeline remaining before the deadline for full implementation of the MDR and other challenges.

RAPS Executive Director Paul Brooks set the tone for the discussion as he emphasized that planning for the unknown, navigating grey areas and adjusting regulatory strategy along the way is the essence of what regulatory professionals do. At the same time, Brooks acknowledged that the current uncertain regulatory environment makes this perhaps one of the most challenging periods ever for Europe’s healthcare products sector. Throughout the ensuing discussion, panelists returned to the concept of ‘navigating the grey.’

The lack of notified bodies (NBs) designated under the new regulations remains a major concern among panelists. Only one NB has been officially designated so far, although the European Commission’s Erik Hansson revealed that a second designated NB will be announced shortly. It was also revealed that 47 NBs have applied to date, 38 under MDR and nine under IVDR.

Another key takeaway from the opening session, according to panelist Gert Bos of Qserve, who is also RAPS President-Elect, is “the fact that authorities are working on a plan B,” though “not necessarily the Commission, because they have no way to extend the timelines.” Various national authorities are working together, looking at possible ways certain medical devices could stay on the market under national laws or exemptions, said Bos.

There was a general acknowledgment among panelists that all stakeholders—authorities, NBs, industry, etc.—are learning together how to make the switch from the old directives to the new regulations. Industry leaders emphasized that it is essential for device and IVD manufacturers to prepare as much as possible despite the current lack of NBs or the absence of needed guidance.

Another big issue among pharmaceutical companies raised during the discussion is article 117 of MDR on medicines with an integral medical device. The European Medicines Agency (EMA) is working to clarify NB involvement in such products. Brexit adds another element of complexity as, historically, consultations of devices with medicines have been completed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Despite concerns about the implementation timeline and other challenges, most agreed that the MDR will bring benefits, including greater transparency, Unique Device Identifiers and a new Eudamed.